MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving morphine (unknown concentration and dose) and prialt (unknown concentration and dose) via an implantable pump for an unknown indication for use.It was reported a problem appeared during the filling of the pump.The event date was unknown.It was stated there were very big differences between the volumes announced by the n'vision and the volume found in the pump.It was stated the hcp had the "impression that the pump flight.Because during fillings, there were differences of very important volumes.Indeed, at the level of the septum, it would seem that the pump flight.The nurses use needles of 20 gauges which certainly conned the septum and caused the flights." it was stated no troubleshooting was performed.By precaution, the hcp preferred to change the pump and catheter.The replacement occurred on (b)(6) 2018.When prompted for contributing factors to the event, the response was, "for two once, the stomach of the patient pearled at the time of the filling." the issue was resolved.The patient status was alive - no injury.The pump and catheter would be returned.No further complications were reported or anticipated.The patient was receiving morphine (1.5 mg/ml at 0.6994 mg/day) and prialt (4.0 mg/ml at 1.8651 mg/day).The volume the pump announced was 16.5 ml and the representative found 0 ml.When asked what "pump flight" means, the representative responded, "none, it¿s a mistake." when asked what "conned the septum" means, the representative responded, "the septum is the center of the pump." when asked what "stomach of the patient pearled" means, the representative responded, "the drug is flowing through the patient's skin." the representative stated the model of the patient's catheter was 8780.The patient did not experience any symptoms.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7611446
• MDR Text Key: 111398635
• Report Number: 3004209178-2018-13699
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention